Pain management after inguinal hernia surgery
A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of CPL-01 in the Management of Postoperative Pain After Open Inguinal Herniorrhaphy
This study is testing if a local anaesthetic injection can help people feel less pain after inguinal hernia surgery compared to other treatments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 504 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Cali Pharmaceuticals LLC Industry-sponsored |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT05813847 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a local anaesthetic injection (CPL-01) compared to a positive control and a negative control in managing postoperative pain following inguinal hernia repair. Participants will be monitored after receiving the treatment to assess pain levels and overall recovery. The study aims to determine if the local anaesthetic can provide better pain relief than the other control options. It is a Phase 3 interventional trial, indicating a focus on evaluating the treatment's efficacy in a larger patient population.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 75 who are scheduled for inguinal hernia repair and meet specific health criteria.
Not a fit: Patients with a history of inguinal hernia surgery or those with concurrent painful conditions requiring analgesics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing inguinal hernia surgery.
How similar studies have performed: Other studies have shown promising results with local anaesthetic interventions for postoperative pain management, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to sign Informed Consent * Scheduled to have inguinal hernia repair * Be a reasonably healthy adult 18 - 75 years of age * Body mass index ≤ 39 kg/m2 * If biologically female, not pregnant or planning to become pregnant * If biologically male, using acceptable birth control * Be willing and able to complete study procedures Exclusion Criteria: * Previously inguinal herniorrhaphy * Concurrent painful condition that may require analgesic treatment * History or clinical manifestation of significant medical, neuropsychiatric, or other condition, significant abnormal clinical laboratory test value, or known bleeding abnormality that could preclude or impair study participation * Clinically significant existing arrhythmia, bundle branch block or abnormal ECG, myocardial infarction, or coronary arterial bypass graft surgery within the prior 12 months * History of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency. * Impaired liver function (e.g., alanine aminotransferase \[ALT\] \> 3 × upper limit of normal \[ULN\] or total bilirubin \> 2 × ULN), active hepatic disease, or cirrhosis. * Impaired renal function (e.g., creatinine \> 1.5 × ULN). * Malignancy in the past year * Known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
Where this trial is running
Salt Lake City, Utah
- Todd Bertoch — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Erol Onel
- Email: e.onel@calibiosciences.com
- Phone: 2038376500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.